Certification

Certification

While ISO uses the term “certifying body” (because they certify the management systems of companies), many organizations in the USA use the term “registrar” (because they maintain a register of certified companies). Same concept, just different words. Choosing a relationship with a certifying body is an important decision. First - Always look for an accredited organization – this means that, like you, they are audited and monitored, and meet the stringent requirements of both the ISO requirements for certifying, and the requirement of their accrediting body. This ensures that you are being certified by an organization worth trusting.
Part of any quality management system (QMS) or environmental management system (EMS) is checking to see if you are really doing what you claim. Accountants do that for your finance department. Quality Control does that for your product. Internal auditors do that for your management system. I’m often asked “why can’t I hire someone outside to come and do audits for us?” While that sounds logical, it’s kind of like saying “why can’t I stop brushing my teeth and have the dentist clean them for me?” It would get pretty scary in between visits.
Sunday, 25 October 2009 17:05

What is ISO 13485 & why do I need it?

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ISO 13485:2003 lists the International Standards Organization requirements for quality management systems for medical devices. Like many of ISO's 17,500 different standards, ISO 13485 takes the core quality management concepts of ISO 9001:2008 and adapts them to the medical device industry. The ISO technical committee for this standard took input from the Global Harmonization Taskforce and from food and drug agencies around the world, to ensure that those who pursued 13485 certification would be well-positioned to meet the requirements of a variety of medical device regulatory bodies – a true benefit to those designing, manufacturing and marketing anything to the medical device industry.
What do you think of when asked if you do design--engineers? Original concept development? What about processes development? Or reverse engineering? While this is always a hotly disputed and needlessly feared area of ISO 9001 requirements, it has a much wider application than most of us initially assume. Here is the definition of design found in ISO 9000:2005:3.4.4: design and development is a set of processes (3.4.1) that transforms requirements (3.1.2) into specified characteristics (3.5.1) or into the specification (3.7.3) of a product (3.4.2), process (3.4.1) or system (3.2.1) NOTE 1 The terms “design” and “development” are sometimes used synonymously and sometimes used to define different stages of the overall design and development process. NOTE 2 A qualifier can be applied to indicate the nature of what is being designed and developed (e.g. product design and development or process design and development). There are a lot of nuances in there. Many different types of engineers are all involved in design (not only mechanical, electrical and software but also, by ISO’s definition, process engineers and system…
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